By Jeff Overley

Law360 (April 20, 2020, 5:44 PM EDT) -- In this edition of Coronavirus Q&A, one of Covington & Burling LLP's top life sciences lawyers discusses strengths and weaknesses of the U.S. Food and Drug Administration's response to COVID-19 and how federal oversight of diagnostic testing should change to accelerate the nation's economic revival.

Scott Danzis, co-chair of Covington's life sciences and medical devices practice, shared the insights as part of a series of interviews Law360 is conducting with law firm practice leaders about lessons learned and fast-evolving legal work during the coronavirus pandemic.

A Washington, D.C.-based partner, Danzis has been with Covington for more than a decade, and he served at the FDA from 2006 to 2008 as special assistant to the agency's chief counsel. Danzis specializes in medical devices as well as diagnostic tests, which have soared into the public consciousness during the coronavirus crisis and become one of the hottest topics at the White House's nightly coronavirus briefings.

This interview has been edited for length and clarity.

Let's start with the clients you're working with these days — what types of companies are coming to you?

Our team works with traditional medical device companies both on the therapeutic and diagnostic sides, and we also are working extensively with pharmaceutical clients that are involved in medical device issues. 

What's been interesting about the last few weeks is that in addition to traditional drug and device clients, we've had dozens of companies that aren't in this space jump in to produce all sorts of different products, everything from PPE — personal protective equipment — to ventilator parts or full ventilators, to you name it across the spectrum of medical devices, in an effort to really help out in this situation.

So it's not just medical device and pharma companies that are used to this regulated space. We're also working with lots of other nonregulated companies that are trying to help out with the situation.

What kinds of advice are you providing to nontraditional manufacturers?

The primary categories of advice that we're providing are, first, explaining FDA's requirements to make a medical device, and second, whether there are product liability concerns or protections that are available to those companies.

And there's a third bucket of government contracting issues: how they work with the federal, state and local governments to distribute their products in connection with those public health responses.

What questions are you getting from traditional manufacturers, such as device and test makers?

There's a host of different things that have arisen. Probably the most simple issue is for companies that have products that are not currently FDA-cleared or FDA-approved, and they want to interface with the FDA to get an Emergency Use Authorization. We're helping dozens of companies understand what the requirements are and understand what they need to do to interface with FDA.

For other companies that are traditional manufacturers of these kinds of products, they may have an approved product, but now they need to ramp up production. Using that as an example, we're working with companies that are seeking to ramp up production of ventilators. So, how do you get that system up and running in a matter of days? That has been a challenge but also a really incredible effort that has been going on.

What strengths and weaknesses in FDA regulations has this crisis revealed?

I think FDA has done an admirable job of bringing down some of its traditional ways of doing business, in terms of waiving requirements and being flexible and allowing products to enter the market and our medical system without their traditional review.

I don't want to be too critical of FDA, but certainly at the beginning of this process, I think it was a real mistake by the agency not setting up a plan early on to allow laboratories to develop their own tests. And so that traditional way of FDA overseeing the operations of laboratories — I think that is an issue that was highlighted in this crisis.

There is sort of an ongoing debate about how much authority FDA has over laboratory operations, and I think this current situation has raised some questions as to whether FDA should be having that oversight role of laboratory operations.

What's your sense of how well we're doing with access to COVID-19 tests?

I'll say a couple things. I think that the response of the laboratories and commercial manufacturers to [increase] testing has been really incredible. They're expending a ton of resources to make drive-through facilities available or other facilities available, to work with FDA on a rapid-fire basis to get the EUAs. It's just been amazing, and I think it's really something we should be proud of.

That said, I think the overall effort to make tests available has been a little disjointed, and obviously it was initially delayed. So we're still trying to ramp up to the level we need to be.

The other piece that I think is important to talk about is that in order for us to really, truly get back to work and really open up our economy and our world, there's going to have to be much more broad-based testing outside of the traditional testing facilities. What I mean by that is there should be some testing that's available at a community level through the very basic screening tests.

And I think the government's going to have to become much more flexible on how that happens. Eventually, there will have to be some sort of test that can be performed either by laypersons or by nurses and pharmacists and the like, and right now we haven't gotten there.

What else could the agency do to get coronavirus tests on the market sooner rather than later?

Right now, it still is a little bit of a patchwork tapestry, if you will, of different policies [on test authorizations and approvals]. You have certain policies to allow serological tests to enter the market without FDA review. But then if you want to offer the same test for use at the point of care, you do need an EUA. Then there are the molecular tests [to diagnose infections], which can be initially distributed for 15 days but then need FDA approval.

So there's a lot of different tests that are out there, and it's really unclear to a lot of the specialty hospitals and other health care [providers] which tests they should be accessing and where they have to be performed. There's just a lot of confusion about that whole situation, and I think the agency perhaps could do a better job of clarifying which tests are available and which settings they can be used in. That's one issue that immediately comes to mind.

--Editing by Aaron Pelc.

Check out Law360's previous installments of Coronavirus Q&A.

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